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BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus

Primary Purpose

Obesity

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Lorcaserin 10 mg once daily (QD)

Lorcaserin 10 mg twice a day (BID)

Matching Placebo

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, weight loss, lorcaserin, APD356, BLOOM-DM, hypertension, dyslipidemia, sleep apnea, glucose tolerance, cardiovascular disease, Arena

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Overweight/obese men and women with type 2 diabetes mellitus that is managed with oral anti-hyperglycemic agent(s).
Body mass index (BMI) 27 to 45 kg/m2, inclusive.
Ability to complete a 1 year study

Exclusion Criteria:

Pregnancy
Use of insulin in any form, exenatide (Byetta) or pramlintide (Symlin) within 3 months prior to screening
History of symptomatic heart valve disease
Serious or unstable current or past medical conditions

Sites / Locations

Arena Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Lorcaserin 10 mg QD

Lorcaserin 10 mg BID

Matching Placebo

Arm Description

Lorcaserin 10 mg tablet each morning and placebo tablet each evening

Lorcaserin 10 mg tablet each morning and evening

Matching placebo tablet each morning and evening

Outcomes

Primary Outcome Measures

Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52

The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.

Secondary Outcome Measures

Percent Change in Body Weight From Baseline to Week 52

The percent change in body weight (kg) from baseline to week 52.

Full Information

NCT ID

NCT00603291

First Posted

January 17, 2008

Last Updated

September 19, 2019

Sponsor

Eisai Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00603291

Brief Title

BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus

Official Title

A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients With Type 2 Diabetes Mellitus Managed With Oral Hypoglycemic Agent(s)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eisai Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus treated with metformin, sulfonylurea (SFU), or either agent in combination with other oral hypoglycemic agents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

obesity, weight loss, lorcaserin, APD356, BLOOM-DM, hypertension, dyslipidemia, sleep apnea, glucose tolerance, cardiovascular disease, Arena

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

604 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lorcaserin 10 mg QD

Arm Type

Experimental

Arm Description

Lorcaserin 10 mg tablet each morning and placebo tablet each evening

Arm Title

Lorcaserin 10 mg BID

Arm Type

Experimental

Arm Description

Lorcaserin 10 mg tablet each morning and evening

Arm Title

Matching Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo tablet each morning and evening

Intervention Type

Drug

Intervention Name(s)

Lorcaserin 10 mg once daily (QD)

Other Intervention Name(s)

APD356

Intervention Description

Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.

Intervention Type

Drug

Intervention Name(s)

Lorcaserin 10 mg twice a day (BID)

Other Intervention Name(s)

APD356

Intervention Description

Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.

Intervention Type

Drug

Intervention Name(s)

Matching Placebo

Intervention Description

Matching placebo tablet each morning and evening for a duration of 52 weeks.

Primary Outcome Measure Information:

Title

Co-primary Endpoint- Percentage of Participants Achieving Greater Than or Equal to 5% Weight Loss From Baseline to Week 52

Description

The percentage of patients with a reduction from baseline body weight of 5% or more after 52 weeks.

Time Frame

Baseline and Week 52

Secondary Outcome Measure Information:

Title

Percent Change in Body Weight From Baseline to Week 52

Description

The percent change in body weight (kg) from baseline to week 52.

Time Frame

Baseline and Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Overweight/obese men and women with type 2 diabetes mellitus that is managed with oral anti-hyperglycemic agent(s). Body mass index (BMI) 27 to 45 kg/m2, inclusive. Ability to complete a 1 year study Exclusion Criteria: Pregnancy Use of insulin in any form, exenatide (Byetta) or pramlintide (Symlin) within 3 months prior to screening History of symptomatic heart valve disease Serious or unstable current or past medical conditions

Facility Information:

Facility Name

Arena Pharmaceuticals, Inc.

City

San Diego

State/Province

California

ZIP/Postal Code

92121

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28345809

Citation

Magkos F, Nikonova E, Fain R, Zhou S, Ma T, Shanahan W. Effect of lorcaserin on glycemic parameters in patients with type 2 diabetes mellitus. Obesity (Silver Spring). 2017 May;25(5):842-849. doi: 10.1002/oby.21798. Epub 2017 Mar 27.

Results Reference

derived

PubMed Identifier

27888609

Citation

Weissman NJ, Smith SR, Fain R, Hall N, Shanahan WR. Effects of lorcaserin on pre-existing valvulopathy: A pooled analysis of phase 3 trials. Obesity (Silver Spring). 2017 Jan;25(1):39-44. doi: 10.1002/oby.21695. Epub 2016 Nov 26.

Results Reference

derived

PubMed Identifier

27659698

Citation

Handelsman Y, Fain R, Wang Z, Li X, Fujioka K, Shanahan W. Lorcaserin treatment allows for decreased number needed to treat for weight and glycemic parameters in week 12 responders with >/=5% weight loss. Postgrad Med. 2016 Nov;128(8):740-746. doi: 10.1080/00325481.2016.1240591. Epub 2016 Oct 19.

Results Reference

derived

PubMed Identifier

27389084

Citation

Pi-Sunyer X, Shanahan W, Fain R, Ma T, Garvey WT. Impact of lorcaserin on glycemic control in overweight and obese patients with type 2 diabetes: analysis of week 52 responders and nonresponders. Postgrad Med. 2016 Aug;128(6):591-7. doi: 10.1080/00325481.2016.1208618. Epub 2016 Jul 18.

Results Reference

derived

PubMed Identifier

27206567

Citation

Nguyen CT, Zhou S, Shanahan W, Fain R. Lorcaserin in Obese and Overweight Patients Taking Prohibited Serotonergic Agents: A Retrospective Analysis. Clin Ther. 2016 Jun;38(6):1498-1509. doi: 10.1016/j.clinthera.2016.04.004. Epub 2016 May 17.

Results Reference

derived

PubMed Identifier

23661689

Citation

Weissman NJ, Sanchez M, Koch GG, Smith SR, Shanahan WR, Anderson CM. Echocardiographic assessment of cardiac valvular regurgitation with lorcaserin from analysis of 3 phase 3 clinical trials. Circ Cardiovasc Imaging. 2013 Jul;6(4):560-7. doi: 10.1161/CIRCIMAGING.112.000128. Epub 2013 May 9.

Results Reference

derived

PubMed Identifier

22421927

Citation

O'Neil PM, Smith SR, Weissman NJ, Fidler MC, Sanchez M, Zhang J, Raether B, Anderson CM, Shanahan WR. Randomized placebo-controlled clinical trial of lorcaserin for weight loss in type 2 diabetes mellitus: the BLOOM-DM study. Obesity (Silver Spring). 2012 Jul;20(7):1426-36. doi: 10.1038/oby.2012.66. Epub 2012 Mar 16.

Results Reference

derived

Links:

URL

http://www.arenapharm.com

Description

Arena Pharmaceuticals, Inc. Home Page

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BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus

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